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Novel Pertussis Vaccines: Challenge Models ‘Promising’ But Need More Work

 
• By Michael McCaughan

A US FDA Advisory Committee responded enthusiastically to the potential use of challenge models to enable pivotal trials of novel pertussis vaccines, but most members suggested more refinements are needed before they are ready to use.

A company wants to initiate a pertusis vaccine trial using a human challenge model, but the FDA is unsure of the idea. (Shutterstock)

The US Food and Drug Administration and its vaccine advisors are excited by developing pertussis challenge models but suggested the models likely need more work before they could enable pivotal trials of novel vaccine candidates.

Key Takeaways
  • The FDA, as well as VRBPAC members, do not seem ready to accept challenge models for vaccine clinical trials.
  • Sanofi said the idea needs more research, while ILiAD Biotherapeutics said a Phase III study using one of the models could be started in the near term

The FDA asked its Vaccines and Related Biological Products Advisory Committee to comment on the potential utility of Controlled Human Infection Models (CHIMs) in pivotal studies to support

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